Collegium's painkiller gets green light from FDA panel (updated)

Acura Pharmaceuticals

11/09/2015 22:36

(Adds details, background) 
    Sept 11 (Reuters) - Collegium Pharmaceutical Inc's  COLL.O  
experimental opioid painkiller moved one step closer to approval 
after a panel of outside advisers to the U.S. Food and Drug 
Administration unanimously voted in favor of the drug. 
    The FDA panel's vote also was contrary to a recommendation 
by FDA staff, which on Wednesday expressed concerns that the 
oral painkiller could be wrongly used, leading to an overdose. 
 ID:nL4N11F47G  
    The panel voted 23 to 0 in favor of approving the drug. 
    The FDA is not obliged to follow the advice of its advisory 
panels, but usually does. 
    Collegium's long-acting experimental oxycodone pill, to be 
sold as Xtampza if approved, is meant to be taken after a meal 
to provide maximum pain relief. 
    The FDA staff had said if the drug was taken without food, 
it could lead to insufficient pain control, which in turn could 
contribute to overdosing and misuse. 
    The abuse of opioids - a class of drugs that include heroin 
and prescription painkillers - has long been a concern. An 
overdose of such drugs can produce euphoric highs, and even 
disrupt parts of the brain that control breathing. 
    An estimated 46 people die everyday in the United States 
from overdosing on opioid painkillers, according to The Centers 
for Disease Control and Prevention. 
    Collegium has proposed to make clear on the label that 
Xtampza, its lead drug in development, should only be taken 
after eating. 
    The FDA panel's vote of approval for Xtampza is also a 
positive for other companies developing abuse-deterrent version 
of painkillers. 
    Pernix Therapeutics Holdings Inc  PTX.O , Egalet Corp 
 EGLT.O , KemPharm Inc  KMPH.O , IntelliPharmaCeutics 
International Inc  I.TO , Pain Therapeutics Inc  PTIE.O  and 
Acura Pharmaceuticals Inc  ACUR.O  are among the drugmakers 
developing abuse-deterrent painkillers. 
    However, another FDA panel on Thursday voted against 
approving Purdue Pharma's fast-acting opioid painkiller due to 
concerns of overdosing.  ID:nL4N11G5HT  
    Trading in Collegium's shares were halted through Friday, 
ahead of the vote. They closed at $13.45 on Thursday. 
 
 (Reporting by Vidya L Nathan in Bengaluru; Editing by Savio 
D'Souza) 
 ((vidya.loganathan@thomsonreuters.com;; within U.S. +1 646 223 
8780; outside U.S. +91 80 6749 6137;; Reuters Messaging: 
vidya.loganathan.thomsonreuters.com@reuters.net)) 
 
Keywords: COLLEGIUM PHARM FDA/